hepatocellular carcinoma liver cancer
Conditions
Interventions
Patients will be treated with a daily dose of 37.5 mg sunitinib for 21 days
until 48 hours before RFA or partial liver resection.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Histologically proven and documented hepatocellular carcinoma of the liver -Liver-only HCC eligible for RFA and/or resection -Age >= 18 -WHO performance status 0-2 - Adequate bone marrow, liver and renal functions -Written, voluntary informed consent -Patients must be accessible to follow up and management in the treatment centre -Patients must sufficiently understand the Dutch language and must be able to sign the informed consent document. -A life expectancy of at least 3 months.
Exclusion criteria
Exclusion criteria: -Extrahepatic metastases or intrahepatic metastasis not eligible for RFA/resection -CHILD C liver cirrhosis -Patients with evidence or a history of bleeding diathesis -Clinically significant cardiovascular disease -Evidence of serious active infections -Prior chemotherapy or biological therapy for metastatic disease. -Prior radiotherapy on the involved area. -Major surgery within 28 days before the initiation of the study. -Dementia or altered mental status that would prohibit the understanding and giving of informed consent -Pregnant or lactating women. Sexually active patients of childbearing potential must implement effective contraceptive practices during the study when treated with sunitinib. -CNS metastases (CT-Scan not mandatory) -Treatment with any investigational drug within 30 days before the start of the study -Prior allergic reaction to immunoglobulins or immunoglobulin allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to determine changes (tissue/serum biomarkers) in familiar pathways of hepatocellular cancer (HCC) to sunitinib treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| -to correlate the changes in these pathways to FDG-PET scan and 111In- bevacizumab scan results before and after sunitinib treatment -to assess the safety and toxicity of pre-surgery sunitinib in patients with liver-only HCC | — |
Countries
Netherlands
Outcome results
None listed